NC TREK NEO™ 1400300-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08717648232534), received between Nov 10, 2023 and Sep 17, 2026 — classified as 1 death, 6 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (4 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Off-Label Use; Material Rupture; Improper or Incorrect Procedure or Method

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50809973 ↗
• DeathJan 29, 2026Deformation Due to Compressive Stress; Failure to Deflate

  IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT A HEAVILY CALCIFIED RIGHT CORONARY ARTERY, A PERFORATION OCCURRED. THE 3.0 X 20MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS USED TO TREAT THE PERFORATION SUCCESSFULLY; HOWEVER, THE BALLOON COMPLETELY FAILED TO DEFLATE. THE BACK STIFF END OF AN UNSPECIFIED GUIDE WIRE WAS USED IN AN ATTEMPT TO POP THE BALLOON BUT WAS UNSUCCESSFUL. AN ATTEMPT TO SNARE THE BALLOON WAS MADE, BUT ALSO UNSUCCESSFUL. ANOTHER ATTEMPT TO POP THE BALLOON WAS MADE BY CUTTING THE BACKSIDE OF THE BDC SHAFT; HOWEVER, THIS WAS ALSO UNSUCCESSFUL. THE PATIENT WAS TO BE TRANSFERRED TO THE OPERATING ROOM; HOWEVER, DIED DURING TRANSPORT. IN THE PHYSICIAN OPINION, THE FAILURE TO DEFLATE THE BALLOON WAS DUE TO INTERACTION OF THE POSSIBLY KINKED SHAFT AND CALCIUM AND CONTRIBUTED TO THE DEATH. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 24210852 ↗
• MalfunctionNov 24, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A DE NOVO, MILDLY CALCIFIED, MILDLY TORTUOUS LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT IS 90% STENOSED. ONCE AT THE LESION FOR POST-DILATION, THE 3.00X20MM NC TREK NEO RX BALLOON DILATATION CATHETER (BDC) RUPTURED AT 12 ATMOSPHERES DURING THE INITIAL INFLATION. A NEW NC TREK BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23633711 ↗
• MalfunctionSep 22, 2025Difficult to Remove; Material Separation; Difficult to Advance; Difficult to Remove; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RAMUS INTERVENTRICULAR ANTERIOR (RIVA). THE 3X20MM NC TREK NEO BALLOON DILATION CATHETER MET WITH RESISTANCE WITH THE GUIDE CATHETER (GC) AND BECAME STUCK IN THE GC. THE DISTAL THIRD OF THE BDC TORE OFF AND BECAME SEPARATED INSIDE THE GC. THEREFORE, THE GC AND GUIDE WIRE WERE REMOVED AS SINGLE UNIT WITH THE SEPARATED PORTION OF THE BDC. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23111454 ↗
• MalfunctionFeb 12, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED DE NOVO LESION IN THE PROXIMAL LEFT CIRCUMFLEX (PLCX) ARTERY WITH MILD CALCIFICATION AND MILD TORTUOSITY. THE 3X20MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND THE BALLOON WAS INFLATED; HOWEVER, THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 10 ATMOSPHERES (ATM) AFTER 5 SECONDS. THEREFORE, BDC WAS REMOVED FROM THE PATIENT. ROTABLATION WAS PERFORMED AND ANOTHER TREK BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21368654 ↗
• MalfunctionJan 28, 2025Material Separation; Material Separation

  IT WAS REPORTED DURING THE PROCEDURAL PREPARATION THAT THE PROXIMAL SHAFT OF A 3X20MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS NOTED TO SEPARATE. A NEW ABBOTT BALLOON WAS USED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT INVOLVEMENT NOR CLINICAL DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21256523 ↗
• MalfunctionNov 10, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION IN THE PROXIMAL LEFT CIRCUMFLEX (PLCX) WITH 90% STENOSIS, MILD CALCIFICATION AND MILD TORTUOSITY. THE 3.0X20MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS PREPARED PER INSTRUCTIONS FOR USE (IFU) AND THERE WAS NO RESISTANCE WHEN THE PROTECTIVE SHEATH WAS REMOVED. THE BDC WAS ADVANCED WITHOUT RESISTANCE, HOWEVER, RUPTURED DURING THE FIRST INFLATION AT 6 ATMOSPHERES (ATMS) FOR 3 SECONDS. THERE WAS NO RESISTANCE DURING REMOVAL. ANOTHER SAME SIZE NC TREK NEO BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18113976 ↗